COOPERATION IN THE REGULATION OF MEDICAL PRODUCTS
On 2nd August 2021, an Agreement/MoU was signed between Rwanda and the United Republic of Tanzania Governments for collaboration between the NRAs of the 2 countries; Rwanda FDA and TMDA.
The purpose of this MoU is to establish the cooperation for harmonization on regulatory requirements between Rwanda FDA and TMDA, in the following areas of;
- Product Registration
- Good Manufacturing Practices Inspection
- Quality audits
- Good Clinical Practices Inspection
- Clinical Trials Control
- Post-Marketing Surveillance
- Quality Control Laboratory Testing
- Research and Trainings
- Information sharing
- Other regulatory functions.